NOTE: The policies, guidelines, terms, and conditions
stated in this announcement may differ from those used by the FDA. Where
this Funding Opportunity Announcement (FOA) provides specific written
guidance that may differ from the general guidance provided in the grant application
form, please follow the instructions given in this FOA. The FDA does not follow the NIH Page Limitation Guidelines or the Enhanced Peer Review
Scoring Criteria. Applicants are encouraged to consult with FDA Agency Contacts for additional information
regarding page limits and the FDA Peer Review Process.

The intended outcome of this FOA is for microbiological
and chemical food analyses performed on behalf of State manufactured food
regulatory programs to be conducted within the scope of an ISO/IEC 17025:2005
accredited laboratory and the goal of achieving a nationally integrated food
safety system to be further advanced. This will be accomplished by preparing
the primary food testing laboratories for State manufactured food regulatory
programs to achieve and maintain ISO/IEC 17025:2005 laboratory
accreditation. Currently accredited laboratories will also be prepared for
accreditation enhancements. Increased laboratory analyses from ISO/IEC
17025:2005 accredited labs, as would be accomplished through this cooperative
agreement, will in effect serve to increase the analytical capacity for FDA
and enhance efforts to protect the food supply. Data generated by recipient
laboratories will be made available for consideration of FDA enforcement
actions as well as for surveillance purposes and during response to foodborne
outbreaks through eLEXNET. Laboratory accreditation will also assist State
manufactured food regulatory programs in achieving conformance with the
Manufactured Food Regulatory Program Standards (MFRPS).

It is critical that applicants follow the instructions in
the SF
424 (R&R) Application Guide, except where instructed to do otherwise
(in this FOA or in a Notice from the HHS Guide
for Grants and Contracts). Conformance to all requirements (both in
the Application Guide and the FOA) is required and strictly enforced. Applicants
must read and follow all application instructions in the Application Guide as
well as any program-specific instructions noted in Section IV. When the program-specific
instructions deviate from those in the Application Guide, follow the
program-specific instructions. Applications that do not comply with
these instructions may be delayed or not accepted for review.

The Food and Drug Administration (FDA), Office of Regulatory Affairs (ORA)
is announcing the availability of up to $6 million to be awarded under Limited Competition to State food testing laboratories that serve as the primary
servicing laboratory for State manufactured food regulatory programs for
microbiological and chemical analyses. The intended outcome of this FOA is for
microbiological and chemical food analyses performed on behalf of State
manufactured food regulatory programs to be conducted within the scope of an
ISO/IEC 17025:2005 accredited laboratory and the goal of achieving a nationally
integrated food safety system to be further advanced. This will be
accomplished by preparing the primary food testing laboratories for State
manufactured food regulatory programs to achieve and maintain ISO/IEC
17025:2005 laboratory accreditation by an impartial and internationally
recognized accrediting body. Accredited laboratories will also be prepared for
accreditation enhancements, such as accreditation for additional sections within
the laboratory and other activities to expand the scope of accreditation. Increased
laboratory analyses from ISO/IEC 17025:2005 accredited labs, as would be
accomplished through this cooperative agreement, will in effect serve to
increase the analytical capacity for FDA and enhance efforts to protect the
food supply. Data generated by recipient laboratories will be made available
for consideration of FDA enforcement actions as well as for surveillance
purposes and during response to foodborne outbreaks through eLEXNET.
Laboratory accreditation will also assist State manufactured food regulatory
programs in achieving conformance with Standard Ten of the Manufactured Food
Regulatory Program Standards (MFRPS).

Laboratory accreditation attests to the competency and
technical capability of a laboratory to perform specific tasks. The results
generated are defensible to a recognized standard that is independent of lab
personnel or other changes. In addition, accreditation supports the
traceability of technical results generated by a laboratory. In the event of
a large-scale terrorist activity or other large-scale events affecting foods or
food products, States and Federal authorities can use laboratory test results
from accredited laboratories to respond at once and enforce regulatory
compliance to protect the safety of the food supply.

Funding will be made specifically to eligible laboratories
to achieve and maintain ISO/IEC 17025:2005 accreditation by an impartial and
internationally recognized accreditation body. Eligible laboratories currently
accredited will also be able to receive funds to maintain accreditation and/or
perform enhancements, such as accreditation for additional sections within the
laboratory and other activities to expand the scope of accreditation. Only
proposed projects designed to obtain, maintain, and/or enhance ISO/IEC
17025:2005 laboratory accreditation will be considered for funding.

The PD(s)/PI(s) will retain the primary responsibility and
dominant role for planning, directing, and executing the proposed project,
however, the cooperative agreement award mechanism will result in substantial
involvement by the FDA. Substantial involvement includes, but is not limited
to:

1) Initial quality management system assessment and gap
analysis

2) Timeline plan execution

3) Monitoring of progress through on-site visits, conference
calls, emails, and other correspondence

Successful applicants will undergo a quality management
system assessment provided by the FDA, Division of Field Science (DFS). The
initial assessment will identify the gaps against the requirements of ISO/IEC
17025:2005 standard followed by the development of a plan to achieve
conformance. The plan will identify the tasks necessary to address
non-conformities, responsible personnel, and timeframes to ensure accreditation
is achieved, maintained, and/or enhance laboratory accreditation within the
established timeframe.

The outcomes of the work provided under this cooperative
agreement are as follows:

2. Strategies for achieving, maintaining, and enhancing a
food testing laboratory's ISO/IEC 17025:2005 accreditation will be developed,
shared, and duplicated on a national basis.

3. The laboratory capacity for FDA to protect the safety of
the food supply will be increased and public health will be further enhanced.

4. Increased sharing of laboratory results generated under
the scope of laboratory accreditation to promote earlier identification and
regulatory response to adulterants in the food supply.

5. Advancement of a nationally integrated food safety
system.

Only the following laboratories will be eligible to apply:

Laboratories that are the primary servicing laboratory for
conducting microbiological and chemical food analyses on behalf of State
manufactured food regulatory programs will eligible to apply. Eligible
laboratories must also participate, or agree to participate within 30 days of
the award, in the Food Emergency Response Network (FERN). These laboratories
must also be developing or maintaining a quality management system that is in
compliance with the managerial and technical requirements of the ISO/IEC
17025:2005 standard. The laboratories must also agree to participate in
proficiency testing programs and share laboratory results through eLEXNET. In
addition, the State manufactured food regulatory program associated with the
laboratory must have a current food safety inspection contract with FDA, or
agree to enter into a food safety inspection contract at the earliest possible
date. The State manufactured food regulatory program must maintain a current
food contract with FDA throughout the cooperative agreement. The State
manufactured food regulatory program must also be enrolled in the MFRPS, or
agree to enroll at the earliest possible date. In addition, the State
manufactured food regulatory program must maintain enrollment in the MFRPS and
demonstrate progress towards conformance throughout the cooperative agreement.

A technical review session will be held for prospective
grantees in February/March 2012. The conference call information will be
provided to prospective grantees that submit a letter of intent. The technical
review session will provide an overview of the submission requirements and
allow prospective grantees an opportunity to ask questions regarding the
application process. Participation in the technical review session is
optional, but strongly encouraged.

The FDA only guarantees one year of funding with the possibility of up to four years of additional, non-competitive support, contingent
on performance and continued availability of federal funds.

These funds are intended to supplement, not replace, State
funding for program improvement and activities. Laboratories funded under these cooperative agreements will be required to provide the previous and subsequent years of State funding to demonstrate that these funds have not replaced State allocations.

2. Background

Over the past several years, the food safety system has
continually encountered risks and emergencies of significant national concern.
Multiple efforts have been undertaken at all levels, including consumers, industry, regulators, and even international organizations, to identify and implement improvements to the food safety system.

a. President’s Food Safety Working Group

An indication of the significant, national interest in food safety is the President’s Food Safety Working Group (FSWG), initiated in March of 2009. The
charge of the FSWG is “To have safe food that does not cause us harm and to enhance our food safety systems by fostering coordination throughout the government including enhancing our food safety laws for the 21st century. These laws will be designed to keep the American people safe and will be enforced.” Chaired by the Secretary of
Health and Human Services and the Secretary of Agriculture, the FSWG recommends a public health-focused approach to food safety that prioritizes prevention, strengthens
surveillance and enforcement, and improves response and recovery.

Furthermore, the FSWG has committed to work to “modernize food safety by building collaborative partnerships with consumers, industry and our regulatory partners and through a transparent process, build a food safety system that will meet the challenges posed by a global food supply in the 21st
century.” These cooperative agreements will help to further achieve these
goals by strengthening the food safety system in a way that will ultimately
extend beyond state borders to have an impact on both national food safety and the associated international food supply.

b. National Integrated Food Safety System

FDA is continuing to work with its state partners to create
a national, fully integrated food safety system that is characterized by effective communication and efficient processes among federal, state, and local partners in the food safety system. Various initiatives, such as the Food Safety Task Force Program, Innovative Food Defense Program, and the programs supported by
these cooperative agreements, work to engage partners across multiple sectors
of the food safety system to collaborate to identify means to improve and optimize the nation’s food safety system.

c. Food Safety Modernization Act

The FDA Food Safety Modernization Act (FSMA), signed into
law on January 4, 2011, provides FDA with tools to better protect public health
by strengthening the food safety system. It enables FDA to focus on preventing
food safety problems rather than reacting to problems after they occur. It also
provides FDA with new enforcement authorities designed to achieve higher rates
of compliance with prevention- and risk-based food safety standards and to
better respond to and contain problems when they do occur. These include
authorities such as mandatory recall, expanded administrative detention,
suspension of facility registration, enhanced product tracing abilities, and
additional recordkeeping requirements for high-risk foods. FSMA also gives FDA
important new tools to hold imported foods to the same standards as domestic
foods.

FSMA directs FDA to build an integrated national food safety
system in partnership with State and local authorities, explicitly recognizing
that all food safety agencies need to work together in an integrated way to achieve
national public health goals. FSMA identifies some key priorities in working
with partners in areas, such as: reliance on Federal, State, and local agencies
for inspections; improving foodborne illness surveillance; and leveraging and
enhancing State and local food safety and defense capacities.

Specifically, TITLE II—IMPROVING CAPACITY TO DETECT AND
RESPOND TO FOOD SAFETY PROBLEMS, section 202(b)(1) provides that not later than
30 months after the January 4, 2011, date of enactment of FSMA, food testing
shall be conducted by Federal laboratories or non-Federal laboratories that
have been accredited for the appropriate sampling or analytical testing
methodology or methodologies by a recognized accreditation body on the registry
established by the Secretary.

d. Food and Drug Administration Amendments Act of 2007
(FDAAA)

FDAAA amended the FD&C Act to require FDA to work with
the States to undertake activities to assist in improving food safety. Section 1004 of FDAAA states:

SEC. 1004. STATE AND FEDERAL COOPERATION

(a) IN GENERAL.—The Secretary shall work with the States in
undertaking activities and programs that assist in improving the safety of food, including fresh and processed produce, so that State food safety programs and activities conducted by the Secretary function in a coordinated and cost-effective manner.
With the assistance provided under subsection (b), the Secretary shall
encourage States to—

(1) Establish, continue, or strengthen State food safety programs, especially with respect to the regulation of retail commercial food establishments; and

(2) Establish procedures and requirements for ensuring that
processed produce under the jurisdiction of State food safety programs is not
unsafe for human consumption.

(b) ASSISTANCE.—The Secretary may provide to a State, for planning, developing, and implementing such a food safety program—

(c) SERVICE AGREEMENTS.—The Secretary may, under an agreement entered into with a federal, State, or local agency, use, on a reimbursable
basis or otherwise, the personnel, services, and facilities of the agency to
carry out the responsibilities of the agency under this section. An agreement
entered into with a State agency under this subsection may provide for training of State employees.

e. Import Safety Action Plan (ISAP)

The Import Safety Action Plan acknowledges the value of
mutual leveraging of State and Federal resources and recommends consideration of cooperative agreements to increase information sharing. Specifically, the
ISAP provides as follows:

Federal-State Rapid Response

Recommendation 12 – Maximize Federal-State Collaboration.

The roles of and the resources used by the federal government and the States in import safety are complementary. States possess legislative
authority and resources to respond to unsafe imported products within their
jurisdiction. The federal government can take steps to interdict unsafe imported goods at ports-of-entry. Should an unsafe product enter domestic commerce, federal departments and agencies often work with State authorities to track
it down, seize it, notify the public if it has already been purchased by consumers, and impose appropriate penalties on domestic entities who violate U.S. law. Also, both the federal government and States may have access to information
relevant to protecting consumers that the other does not possess. For example,
federal departments and agencies may have relevant information about the
foreign source of the imported product and about the importer. This information
can help State officials track down an unsafe imported product within their jurisdiction. On the other hand, State officials may identify an unsafe
imported product during transport or at the point-of-sale, if the product does get into the country, and can tip-off federal officials to prevent future shipments
from entering domestic commerce.

Several federal departments and agencies already collaborate closely with State authorities to protect consumers. For example, FDA has
contracts and cooperative agreements with State governments to share
information, conduct joint inspections, and collaborate on laboratory analyses.
Greater mutual leveraging of State and federal resources can further enhance
consumer protection.

12.1 Consider cooperative agreements between the federal inspection agencies and their State counterparts for greater information-sharing. Such
cooperative agreements would not infringe on the statutory authorities of federal or State regulators and would encourage a coordinated effort that would result in a more rapid and effective response. Establishing clear procedures and points-of-contact for information sharing and joint enforcement efforts can further enhance
the effectiveness of federal-State actions to limit exposure and potential harm to consumers if an unsafe imported product makes it into domestic commerce.

The food safety regulatory system in the United States is a tiered system that involves Federal, State, Local and Tribal governments. The
Food and Drug Administration (FDA) is responsible for ensuring that all foods
moving in interstate commerce, except those under United States Department of
Agriculture jurisdiction, are safe, wholesome, and labeled properly.

State agencies conduct inspection and regulatory activities
that help ensure that safe food is produced, processed, or sold within their
jurisdictions. Many State agencies also conduct food plant inspections under
contract with the FDA. These inspections are performed under the States' laws
and authorities or the provisions of the Federal Food, Drug, and Cosmetic Act
(FD&C Act) or both. To maximize the use of resources among the FDA and the
State governments, particularly when their jurisdictions overlap, their inspection
programs should be equivalent in effect.

In June 2000, the Department of Health and Human Services'
Office of the Inspector General (OIG) released a report of FDA's oversight of
State contracts. In this report, the OIG recommended that FDA take steps to
promote "equivalency among Federal and State food safety standards,
inspection programs, and enforcement practices." In response to their
findings, FDA established a committee to develop a set of quality standards for
manufactured food regulatory programs. The committee was comprised of officials
from FDA and from State agencies responsible for the regulation and inspection
of food plants.

The Manufactured Food Regulatory Program Standards (MFRPS)
establish a uniform foundation for the design and management of State programs
responsible for the regulation of food plants. The elements of the program
standards describe best practices of a high-quality regulatory program.
Achieving conformance with them will require comprehensive self-assessment on
the part of a State program and will encourage continuous improvement and
innovation.

The program standards are comprised of ten standards that
establish requirements for the critical elements of a regulatory program
designed to protect the public from food borne illness and injury. These
elements include the program's regulatory foundation, staff training,
inspection, quality assurance, food defense preparedness and response, food borne
illness and incident investigation, enforcement, education and outreach,
resource management, laboratory resources, and program assessment.

FDA will use the program standards as a tool to improve contracts
with jurisdictions. The program standards will assist both FDA and the State jurisdictions
in fulfilling their regulatory obligations. FDA recognizes that full use and conformance
of the program standards by State jurisdictions will take several years. Such
jurisdictions will, however, be expected to implement improvement plans to
demonstrate that they are moving toward full conformance. The goal is to
implement a risk-based food safety program by establishing a uniform basis for
measuring and improving the performance of manufactured food regulatory
programs in the United States. The development and conformance of these program
standards will help Federal and State programs better direct their regulatory
activities at reducing foodborne illness hazards in food plants. Consequently,
the safety and security of the United States food supply will improve.

Leads: HHS / FDA, USDA, CPSC, EPA Time Frame: Long Term

12.2 Review admissibility policies to improve the use of evidence and laboratory results from State investigations of imported products. Currently, there
are limitations on the use of State-developed evidence in federal court cases due to the gathering, analysis and retention of such evidence by non-federal government entities. Being able to use this evidence would make it easier for federal departments and agencies to take enforcement actions against bad actors.

Leads: DOJ, HHS / FDA, USDA, CPSC Time Frame: Short Term

FDA is offering these cooperative agreements to laboratories
supporting State manufactured food regulatory programs to achieve, maintain,
and/or enhance ISO/IEC 17025:2005 laboratory accreditation. Laboratory
accreditation also supports state manufactured food regulatory programs in
achieving conformance with the Manufactured Food Regulatory Program Standards
(MFRPS), Standard 10. Laboratory accreditation will contribute to production
of accurate and reliable test data and as a result a quicker acceptance of
analytical results by FDA and other regulatory agencies for enforcement
actions, surveillance purposes and during response to foodborne outbreaks.

Section II. Award
Information

Funding Instrument

Cooperative Agreement: A support mechanism used when there
will be substantial Federal scientific or programmatic involvement.
Substantial involvement means that, after award, FDA scientific or program
staff will assist, guide, coordinate, or participate in project activities.

Application Types Allowed

New

The OER
Glossary and the SF 424 (R&R) Application Guide provide details on
these application types.

Funds Available and Anticipated Number of Awards

The number of awards is contingent upon FDA
appropriations, and the submission of a sufficient number of meritorious
applications.

FDA intends to fund an estimate of 20 - 30 awards,
corresponding to a total of up to $6,000,000, for fiscal year 2012. Future
year amounts will depend on annual appropriations.

FDA intends to commit up to $6,000,000 in FY 2012.

Awards of no more than $300,000 per year for laboratories
seeking to obtain ISO/IEC 17025:2005 accreditation will be given.

Awards of no more than $150,000 per year for currently
accredited laboratories seeking to maintain and enhance the scope of ISO/IEC
17025:2005 laboratory accreditation will be given.

Award is contingent upon FDA appropriations, and the
submission of a meritorious application. Future year amounts will
depend on annual appropriations and performance.

Award Budget

Application budgets are limited to up to $300,000 (direct
and indirect costs) per year for laboratories seeking to obtain ISO/IEC
17025:2005 accreditation but need to reflect actual needs of the proposed
project.

Application budgets are limited to up to $150,000 (direct
and indirect costs) per year for currently accredited laboratories seeking to
maintain and enhance the scope of ISO/IEC 17025:2005 laboratory accreditation
but need to reflect actual needs of the proposed project.

Award Project Period

The total project period for an application requesting
support may not exceed five years.

FDA grants policies as
described in the HHS Grants
Policy Statement will apply to the
applications submitted and awards made in response to this FOA.

Section III. Eligibility
Information

1. Eligible Applicants

Eligible Organizations

Governments

State Governments

State Governments - This opportunity is only available to
State food safety laboratories that meet the following criteria:

State food testing laboratories that serve as the primary
chemical and microbiology food analyses servicing laboratory for State
manufactured food regulatory programs to allow for regulatory action to be
considered and pursued by a State regulatory agency or FDA. By enhancing the
sharing of laboratory results between FDA and State manufactured food
regulatory agencies, coordinated and effective approaches to protecting public
health can be achieved.

State food testing laboratories seeking to achieve, maintain, and/or
enhance ISO/IEC 17025:2005 laboratory accreditation by an impartial and internationally
recognized body. Food testing laboratories that achieve, maintain, and enhance
laboratory accreditation will increase the laboratory capacity of FDA.
Laboratory accreditation helps to ensure the laboratory results generated are
technically valid and may be used by FDA and other regulatory agencies for
enforcement actions to protect public health.

Successful laboratory participation in proficiency testing
programs. Successful participation in proficiency testing by a laboratory
provides additional evidence the laboratory is generating reliable analytical
data that may be used for surveillance, response, and enforcement actions by
the FDA.

Laboratories participating, or that agree to participate within 30
days of the award, in the Food Emergency Response Network (FERN). The FERN
allows for Federal and State interagency collaboration and coordination to
support the prevention, preparedness, response, and recovery effects for any
type of food-related emergency, including accidental, intentional, and natural
disaster.

Laboratory commitment to analyze surveillance and emergency
response samples and share the results through eLEXNET. This will serve to
increase the food safety surveillance, detection, and response efforts of the
FDA and other regulatory agencies.

The State manufactured food regulatory program must be under a
current food safety inspection contract with the FDA, or agree to enter into a
food safety inspection contract with FDA at the earliest possible date. The
food safety inspection contract must be maintained with FDA throughout the
cooperative agreement budget and project periods. The foundational work
conducted under the FDA food safety inspection contracts is necessary for the
completion of significant improvements in a nationally integrated food safety
system.

The State manufactured food regulatory program must also be
enrolled in the MFRPS, or agree to enroll in the MFRPS at the earliest possible
date. Enrollment in the MFRPS must be maintained with FDA throughout the
cooperative agreement. The State manufactured food regulatory program must
also demonstrate progress in achieving conformance with the MFRPS. The MFRPS
establishes a uniform foundation for the design and management of State
manufactured food regulatory programs, which serves to advance a nationally
integrated food safety system. Laboratory accreditation will assist the State
manufactured food regulatory program in achieving conformance with Standard 10
of the MFRPS.

Foreign Institutions

Non-domestic (non-U.S.) Entities (Foreign Institutions) are
not eligible to apply.
Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.

Applicant organizations must complete the following registrations
as described in the SF 424 (R&R) Application Guide to be eligible to apply
for or receive an award. Applicants must have a valid Dun and Bradstreet
Universal Numbering System (DUNS) number in order to begin each of the following
registrations.

All Program Director(s)/Principal Investigator(s) (PD(s)/PI(s))
must also work with their institutional officials to register with the eRA
Commons or ensure their existing eRA Commons account is affiliated with the eRA
Commons account of the applicant organization.

All registrations must be completed by the application due date. Applicant
organizations are strongly encouraged to start the registration process at
least 4-6 weeks prior to the application due date.

Eligible Individuals (Program Director(s)/Principal Investigator(s))

Any individual(s) with the skills, knowledge, and resources
necessary to carry out the proposed research as the Program Director(s)/Principal
Investigator(s) (PD(s)/PI(s)) is invited to work with his/her organization to
develop an application for support. Individuals from underrepresented racial
and ethnic groups as well as individuals with disabilities are always
encouraged to apply for FDA support.

FDA will not accept any application in response to this FOA
that is essentially the same as one currently pending initial peer review
unless the applicant withdraws the pending application. FDA will not accept any
application that is essentially the same as one already reviewed.

Section IV. Application and Submission Information

1. Requesting an
Application Package

Applicants must download the SF424 (R&R) application
package associated with this funding opportunity using the “Apply for Grant
Electronically” button in this FOA or following the directions provided at Grants.gov.

2. Content and Form of Application Submission

It is critical that applicants follow the instructions in
the SF424
(R&R) Application Guide, except where instructed in this funding
opportunity announcement to do otherwise. Conformance to the requirements in
the Application Guide is required and strictly enforced. Applications that are
out of compliance with these instructions may be delayed or not accepted for
review.

Although a letter of intent is not required, is not binding,
and does not enter into the review of a subsequent application, the information
that it contains allows FDA staff to estimate the potential review workload and
plan the review.

By the date listed in Part 1. Overview
Information, prospective applicants are asked to submit a letter of intent
that includes the following information:

Descriptive title of proposed research

Name, address, and telephone number of the PD(s)/PI(s)

Names of other key personnel

Participating institutions

Number and title of this funding opportunity

Food contract status with FDA and status of enrollment in the
MFRPS for the State manufactured food regulatory program primarily supported by
the prospective applicant

The forms package associated with this FOA includes all
applicable components, mandatory and optional. Please note that some
components marked optional in the application package are required for
submission of applications for this FOA. Follow all instructions in the SF424
(R&R) Application Guide to ensure you complete all appropriate “optional”
components.

Page Limitations

All page limitations described in the SF424 Application
Guide and the Table of Page
Limits must be followed, with the following exceptions or additional
requirements:

For this specific FOA, the Research Strategy section is limited
to 30 pages.

PHS 398 Research Plan Component

All instructions in the SF424 (R&R) Application Guide
must be followed, with the following additional instructions:

Resource Sharing Plan

Individuals are required to comply with the
instructions for the Resource Sharing Plans (Data Sharing Plan, Sharing Model
Organisms, and Genome Wide Association Studies (GWAS) as provided in the SF424
(R&R) Application Guide, with the following modification:

Generally, Resource Sharing Plans (Data Sharing Plan, Sharing
Model Organisms, and GWAS Sharing Plan) are expected, but they are not
applicable for this FOA.

Appendix

Do not use the Appendix to circumvent page limits. Follow
all instructions for the Appendix as described in the SF424 (R&R)
Application Guide.

3. Submission Dates and
Times

Part I. Overview Information
contains information about Key Dates. Applicants are encouraged to submit in
advance of the deadline to ensure they have time to make any application
corrections that might be necessary for successful submission.

Organizations must submit applications via Grants.gov, the online portal to find and apply for grants
across all Federal agencies. Applicants must then complete the submission
process by tracking the status of the application in the eRA Commons, the electronic system for grants
administration.

Applicants
are responsible for viewing their application in the eRA Commons to ensure accurate
and successful submission.

Information on the submission process and a definition of
on-time submission are provided in the SF424 (R&R) Application Guide.

1) Facilities and work covered under current FDA food safety
inspection contracts cannot be counted towards fulfillment of the cooperative
agreement and must remain distinct and separate from the cooperative
agreement. The State must be able to account separately for fund expenditures un der the food safety inspection contracts and these cooperative agreements.

2) Vehicle purchases are not permitted.

3) Subcontracting to third parties is limited to 25% of each year's award.

4) Cooperative agreement funds may not be utilized for new building construction; however, remodeling of existing facilities is allowed, provided that remodeling costs do not exceed 10% of the grant award amount.

Funding Plan:

Funding for years 2 - 5 will be noncompetitive continuation
of support and depend on performance, program progress, and the availability of Federal funds.

Funds should be requested in the budget to travel to
meetings with FDA program staff about the progress of the project and for
training. A portion of budgeted travel funds should be set aside for key
personnel to attend the annual face-to-face FERN meeting and have key personnel
to attend on-site visits by FDA.

6. Other Submission
Requirements and Information

Applications must be submitted electronically following the
instructions described in the SF 424 (R&R) Application Guide. Paper applications will not be accepted.

For assistance with your electronic application or for more information on the electronic submission
process, visit Applying Electronically.

Important
reminders:All PD(s)/PI(s) must include their eRA Commons ID in the
Credential fieldof the Senior/Key Person Profile Component of the SF
424(R&R) Application Package. Failure to register in the Commons and
to include a valid PD/PI Commons ID in the credential field will prevent the
successful submission of an electronic application to FDA.

The applicant organization must ensure that the DUNS number it provides on the application
is the same number used in the organization’s profile in the eRA Commons and
for the Central Contractor Registration (CCR). Additional information may be
found in the SF424 (R&R) Application Guide.

In order to expedite review, applicants are requested to
notify the ORA Project Officer by email at Wendy.Campbell@fda.hhs.gov when
the application has been submitted. Please include the FOA number and title,
PD/PI name, and title of the application.

The applicant must specifically address the ability to
achieve the following objectives in the cooperative agreement:

1) Demonstrate the ability to implement and maintain a
quality management system that is in compliance with the managerial and
technical requirements of ISO/IEC 17025 and is accredited by an impartial,
independent, and internationally recognized accreditation body;.

2) Demonstrate the ability to fully participate in
initiatives supporting the ISO/IEC 17025:2005 accreditation process and FERN
activities, such as an annual face-to-face meeting, monthly conference calls,
sharing of best practices, on-site visits, and program audits;

3) Demonstrate the ability to share all laboratory data
generated related to food safety through eLEXNET and as requested by the FDA.
Ideally, an electronic data exchange will be established between the laboratory
information management system (LIMS) and eLEXNET;

4) Demonstrate the availability of adequately trained food
program and/or laboratory staff and the criteria and ability to hire and/or
train personnel to meet the deliverables of the cooperative agreement;

5) Provide a properly detailed budget (one for each of the five
years) that is intended achieve, maintain, and/or enhance ISO/IEC 17025:2005
laboratory accreditation;

6) Demonstrate the ability to satisfy the reporting requirements
outlined in section VI.3 of this announcement;

7) Provide the previous year and current funding level
certification for the laboratory program from State funding appropriations;

8) Outline a detailed methodology for program assessment,
improvement, and collaboration to accomplish the work and program
sustainability, as described in this announcement;

9) Provide justification for hiring new staff, including
qualifications, training needs, and new equipment needs;

10) Capability to analyze food samples for chemical and
microbiological hazards utilizing analytical methods within the scope of
accreditation for emergency response and surveillance efforts - an annual
estimate of capability should be provided for chemical and microbiological
testing;

11) Summary description of procedures or processes in place
to evaluate the process for preparing for accreditation;

12) Summary description of procedures in place to monitor
accreditation requirements, including the tracking and monitoring of activities
and training in progress to include a description of the laboratory quality
manual and technical requirements process and procedures.

Laboratories applying for funding through this FOA must
provide a complete description of the facilities, personnel qualifications,
management practices, organization, and a commitment to analyze samples in
their application to include the following:

1) Operational support areas to be used for the project,
including floor diagrams of the laboratories, details about the availability of
ancillary laboratory safety, and support equipment and facilities;

2) Details describing the sample receiving and sample
storage areas and a description of any existing chain-of-custody procedures;

3) Detailed description of laboratory access procedures,
including a description of practices and system which limit access to
laboratory space by unauthorized personnel to include measures in place to
ensure that all staff have sufficient clearance and/or background checks to
work on this project or program;

4) Qualifications of all personnel that will be assigned to
the project, including the quality assurance (QA)/quality control (QC) manager,
QA/QC personnel, and laboratory technical personnel;

6) A detailed description of the proposed upgrades to
existing laboratory facilities to accommodate new equipment, including drawings
and cost estimates;

7) A summary description of any quality management system
in place or under development as it relates to quality control and quality
assurance procedures and practices;

8) A summary description of procedures in place to monitor
food sample workflow, including the tracking and monitoring of sample analyses
in progress, including a description of the laboratory work product review
process and how reports of sample analyses will be provided within reasonable
timeframes;

9) Previous year and current funding level certification
for the laboratory program from State funding appropriations.

1. All key laboratory staff are familiar with the
requirements for implementation and maintenance of the ISO/IEC 17025:2005
standard. Training records required by ISO/IEC 17025:2005 are developed as
well as a training plan for ongoing training to accomplish accreditation.

2. Staffing an independent quality manager position in the
laboratory organization that is qualified and trained in QMS and ISO/IEC
17025:2005. The funded laboratory will submit the contact information of the
quality manager that shall be the point of contact for quality management
system reports and communication with FDA.

5. Participation in an on-site lab assessment by the FDA
Division of Field Sciences and establish a timeline/plan of incremental steps
to accreditation.

6. All data generated by the laboratory is being entered
into eLEXNET and shared with FDA, as requested. Ideally, an automatic,
electronic data exchange is established between the laboratory and eLEXNET.

Years 2 - 3:

1. Create and implement a Quality Manual and Management
System policies and procedures that meets ISO/IEC 17025:2005 requirements.

2. Conduct at least one internal audit and management
review per year to identify non-conformances.

3. Develop an improvement plan to address each
non-conformance, including key personnel responsible, timelines, and tasks.

4. Requirements for all suitable proficiency testing are
met.

5. Active participation in the FERN continues.

6. Participation in on-site lab assessments by FDA to
determine progress to accreditation, and work with FDA to establish a
timeline/plan of incremental steps to accreditation.

7. Adequate training for laboratory to meet the
requirements of ISO/ISE 17025:2005 accreditation and to keep abreast of
scientific and technological advances in relevant areas.

8. All data generated by the laboratory is being entered
into eLEXNET and shared with FDA, as requested. Ideally, an automatic,
electronic data exchange is established between the laboratory and eLEXNET.

Year 4.

1. Submit completed application to accrediting body to
initiate an assessment of the organization.

2. Assessment, or pre-assessment, is conducted by the
accrediting body.

3. Laboratory addresses any areas of non-conformance or
deficiencies noted by responding with a written corrective action response.

4. Requirements for all suitable proficiency testing are
met.

5. Active participation in the FERN continues.

6. Adequate training for laboratory to keep abreast of
scientific and technological advances in relevant areas.

7. All data generated by the laboratory is being entered
into eLEXNET and shared with FDA, as requested. Ideally, an automatic,
electronic data exchange is established between the laboratory and eLEXNET.

Year 5.

1. Accreditation is granted by the accrediting body.

2. Laboratory submits a plan including the designation of
personnel, resources, and funding necessary to maintain accreditation for five
years beyond the cooperative agreement program period. Laboratories are also
encouraged to include plans to enhance the scope of accreditation, in
consultation with the State manufactured food regulatory program, feed program
(if applicable), and the FDA. These accreditation enhancements may include
accreditation for additional sections within the lab and expansion of the
number and/or type of methods.

3. Active participation in the FERN continues.

4. Adequate training for laboratory to keep abreast of
scientific and technological advances in relevant areas.

5. All data generated by the laboratory is being entered
into eLEXNET and shared with FDA, as requested. Ideally, an automatic,
electronic data exchange is established between the laboratory and eLEXNET.

For laboratories currently ISO/IEC 17025:2005 accredited

Year 1.

1. Actively participate in the FERN, including meetings,
conference calls, and other activities.

2. In conjunction with the State manufactured food
regulatory program, feed program (if applicable), and the FDA, identify areas
to enhance the scope of accreditation.

3. Participate in a mentoring program to assist other
laboratories in achieving ISO/IEC 17025: 2005 accreditation.

4. Maintain current ISO/IEC 17025:2005 accreditation.

5. Implement a training program for the laboratory to keep
abreast of scientific and technological advances in relevant areas.

6. All data generated by the laboratory is being entered
into eLEXNET and shared with FDA, as requested. Ideally, an automatic,
electronic data exchange is established between the laboratory and eLEXNET.

Years 2 - 5

1. Enhance the scope of accreditation in consultation with
the State manufactured food regulatory program, feed program (if applicable),
and the FDA. These accreditation enhancements may include accreditation for
additional sections within the lab and expansion of the number and/or type of
methods.

2. Continue to actively participate in the FERN.

3. Continue to participate in a mentoring program to assist
other laboratories in the cooperative agreement in achieving ISO/IEC 17025:2005
accreditation by the end of Year 5.

4. Continue to maintain ISO/IEC 17025:2005 accreditation,
which includes conducting an annual surveillance audit, continuous update and
improvement of the Quality Manual and Management System policies and procedures,
and a three year full system audit required for renewal.

5. Maintain training for the laboratory to keep abreast of scientific and
technological advances in relevant areas.

6. Laboratory submits a plan including the designation of
personnel, resources, training, and funding necessary to maintain accreditation
for five years beyond the cooperative agreement program period.

7. All data generated by the laboratory is being entered
into eLEXNET and shared with FDA, as requested. Ideally, an automatic,
electronic data exchange is established between the laboratory and eLEXNET.

Letters of support or collaboration resulting from a change in
senior/key personnel due to the hiring, replacement, or loss of an
investigator.

Section V. Application Review Information

1.
Criteria

All applications submitted to the FDA are evaluated for
scientific and technical merit through the FDA peer review system.

Only the review criteria described below will be considered
in the review process. All applications submitted to the FDA are evaluated for
scientific and technical merit through the FDA peer review system.

For this particular announcement, note the review criteria
described below (Criteria 1-3) will be considered in the review process.

1. The rationale and design to meet the goals and project
milestones of the cooperative agreement (total weight = 60%);

2. Have adequate program resources (especially staff) and
infrastructure to complete project needs, or the ability to obtain adequate
program resources (weight = 20%);

3. Demonstration that capabilities that can be sustained in
the long-term (five years after the conclusion of the project period; expected
challenges should be documented and addressed). This includes plans to achieve
the incorporation of project-developed capabilities into long-term program work
(weight = 20%).

Note: Only the criteria and scoring described above will be
used for scoring during the review of applications for this announcement.
Reviewers may consider the additional criteria described under "Overall
Impact" (below) as they relate to the criteria described above, but
separate scores will not be give for the items described below.

Overall Impact

Reviewers will provide an overall impact/priority score to
reflect their assessment of the likelihood for the project to exert a
sustained, powerful influence on the research field(s) involved, in
consideration of the preceding review criteria and additional review criteria
(as applicable for the project proposed).

Additional Review Considerations

As applicable for the project proposed, reviewers will
consider each of the following items, but will not give scores for these items,
and should not consider them in providing an overall impact/priority score.

Budget and Period of Support

Reviewers will consider whether the budget and the
requested period of support are fully justified and reasonable in relation to
the proposed research.

If the application is under consideration for funding, FDA
will request "just-in-time" information from the applicant as
described in the HHS Grants
Policy Statement.

A formal notification in the form of a Notice of Award (NoA) will be provided
to the applicant organization for successful applications. The NoA signed by
the grants management officer is the authorizing document and will be sent via
email to the grantee’s business official.

Awardees must comply with any funding restrictions described in Section IV.5. Funding Restrictions. Selection
of an application for award is not an authorization to begin performance. Any
costs incurred before receipt of the NoA are at the recipient's risk. These
costs may be reimbursed only to the extent considered allowable pre-award costs.

The following special terms of award are in addition to, and
not in lieu of, otherwise applicable U.S. Office of Management and Budget (OMB)
administrative guidelines, U.S. Department of Health and Human Services (DHHS)
grant administration regulations at 45 CFR Parts 74 and 92 (Part 92 is
applicable when State and local Governments are eligible to apply), and other
HHS, PHS, and FDA grant administration policies.

Support will be in the form of a cooperative agreement. Substantive
involvement by the awarding agency is inherent in the cooperative agreement
award. Accordingly, FDA will have substantial involvement in the program
activities of the project funded by the cooperative agreement.

Substantive involvement includes, but is not limited to, the
following:

Hosting of face-to-face meetings with all awardees, such as
the annual FERN meeting.

FDA conducting on-site technical sessions with the
grantee.

FDA hosting monthly (or at a frequency chosen by FDA)
conference calls/webinar meetings with individual laboratories and all laboratories
within the cooperative agreement.

FDA assistance in the sharing of information developed by
the grantee to achieve, maintain, or enhance ISO/IEC 17025:2005 accreditation.

FDA assistance in coordinating multi-program pilot
projects.

The program project officer will monitor the recipient periodically. The monitoring may be in the form of telephone conversations, e-mails, or written
correspondence between the project officer/grants management officer and the principal investigator. Periodic site visits with officials of the recipient organization
may also occur. There may be other regular meetings with recipients to assist
in fulfilling the requirements of the cooperative agreement. Monitoring of the
recipient should demonstrate that the laboratory is achieving the goals of the
cooperative agreement and proposal.

The purpose of these cooperative agreements is to advance
efforts for a nationally integrated food safety system by assisting laboratories
that provide laboratory support to State manufactured food regulatory programs
to achieve, maintain, and enhance laboratory accreditation.

The following conditions of the award will apply to all
funded applicants and must be maintained throughout the cooperative agreement.

1. The laboratory must remain the primary servicing
laboratory for conducting microbiological and chemical food analyses on behalf
of the State manufactured food regulatory program to be eligible to apply and
receive funds through this cooperative agreement.

A final progress report, invention
statement, and the expenditure data portion of the Federal Financial Report are
required for closeout of an award, as described in the HHS Grants
Policy Statement.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation
under Federal assistance awards issued in FY2011 or later. All awardees of
applicable FDA grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov
on all subawards over $25,000. See the HHS Grants
Policy Statement for additional information on this reporting
requirement.

Mid-year reports must contain the elements below as
applicable to their proposal and award, but are not limited to, the following:

1) An updated improvement plan demonstrating significant
progress towards implementing a quality management system that will result in
the laboratory receiving ISO/ISE 17025:2005 accreditation for laboratories
seeking ISO/IEC 17025:2005 accreditation within the established timeframe. For
laboratories currently accredited, an updated improvement plan for enhancing
the scope of accreditation and maintaining accreditation within the established
timeframes.

2) A proficiency testing plan and results of participation
in a recognized proficiency testing program(s) to ensure and demonstrate the
quality of the tests performed in the lab.

3) Hiring of new personnel and training of personnel in the
implementation and maintenance of a quality system to achieve, maintain, and/or
enhance ISO/IEC 17025:2005 accreditation. The program must include initial and
ongoing training to ensure consistent quality and continuous improvement,
including assisting laboratory personnel in maintaining current knowledge of
scientific and technological advances in relevant areas.

4) Summary report on the facility inventory that is
maintained by the laboratory.

5) Status report on the installation and operational rea diness of any analytical equipment that is purchased.

6) Summary of laboratory data shared with FDA and other
regulatory agencies, including any regulatory actions taken by FDA or another
regulatory agency or any significant laboratory findings that advanced the
protection of public health.

7) Current funding level certification for the laboratory program
from State funding appropriations.

All recipients must file a final program progress report,
FSR, invention Statement, and disposition of equipment Statement within 90 days after the en d date of the project period as noted on the notice of the cooperative
agreement award.

The final program progress report must provide full written documentation of the project, and summaries of accomplishments and goals, as described in the grant application. The documentation must be in a form and contain sufficient detail such that other State, local, and tribal governments could reproduce the final project. An audit by an independent accrediting body should confer
ISO/ISE 17025:2005 accreditation upon the laboratory. The final program
progress report should also detail the strategy, including commitment of
personnel, resources, and funding, for maintaining of ISO/ISE 17025:2005
accreditation after the completion of the project.

Monitoring Activities

The program project officer and technical advisor will
monitor award recipients periodically. The monitoring may be in the form of
face-to-face meetings, telephone conversations, e-mails, or written correspondence between the project officer/grants management officer/technical advisor and the principal investigator. In addition, periodic site visits with officials of the recipient
organization may also occur to assess progress with achieving, maintaining, or
enhancing the scope of ISO/IEC 17025:2005 accreditation for the laboratory. The
results of these monitoring activities will be recorded in the official
cooperative agreement file and will be available to the grant recipient, upon
request, consistent with applicable disclosure statutes and FDA disclosure regulations. Also, the grantee organization must comply with all special terms
and conditions of the cooperative agreement, including those which state that
future funding of the project will depend on recommendations from the Project
Officer and Technical Advisor.

The scope of the recommendation will confirm that:

1) There has been acceptable progress on the project; 2)
there is continued compliance with all FDA regulatory requirements; 3) if
necessary, there is an indication that corrective action has taken place; and
(4) assurance that any replacement of personnel will meet the laboratory
requirements as well as security background screening.

A final progress report, invention statement, and Financial
Status Report are required when an award is relinquished when a recipient
changes institutions or when an award is terminated.

The Federal Funding Accountability and Transparency Act of
2006 (Transparency Act), includes a requirement for awardees of Federal grants
to report information about first-tier subawards and executive compensation under
Federal assistance awards issued in FY2011 or later. All awardees of
applicable FDA grants and cooperative agreements are required to report to
the Federal Subaward Reporting System (FSRS) available at www.fsrs.gov
on all subawards over $25,000. See the HHS Grants
Policy Statementfor additional information on this reporting
requirement.

Section VII. Agency Contacts

We encourage inquiries concerning this funding opportunity
and welcome the opportunity to answer questions from potential applicants.

Awards are made under the authorization of Sections 301 and 405 of the Public Health Service Act as amended (42 USC 241 and 284) and
under Federal Regulations 42 CFR Part 52 and 45 CFR Parts 74 and 92.